Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 36741–36760 of 38,428 recalls

November 13, 2012· Leica Microsystems, Inc.

Recalled Item: Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a

The Issue: The Instruction for Use 1v9 Ref F and

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 13, 2012· Medtronic Navigation, Inc.

Recalled Item: The Vertex Max Drill Tube is a component within the

The Issue: Medtronic is recalling certain Vertex Max Drill Tubes

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 12, 2012· Becton Dickinson & Company

Recalled Item: BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes

The Issue: BD is conducting a recall of the BD

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 12, 2012· Greatbatch Medical

Recalled Item: Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no.

The Issue: Greatbatch Medical observed some anomalies of the inner

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 12, 2012· Zimmer, Inc.

Recalled Item: Zimmer Spine Ardis Inserter

The Issue: Zimmer Spine has received reports of the PEEK

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardTerminated
November 12, 2012· BioMotion Medical Systems, LLC

Recalled Item: SpineSix consists of a motorized treatment table that is controlled

The Issue: BioMotion is issuing a field correction for all

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 10, 2012· Orthovita, Inc., dBA Stryker Orthobiologics.

Recalled Item: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument -...

The Issue: There have been a few reported cases of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 9, 2012· Cooper Vision Caribbean Corp.

Recalled Item: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses

The Issue: The lenses exceeded the acceptance limit for silicone

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated